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A case of hidden receptacle-adapter incompatibility
B Nowak1, T Voigtlaender, W Eckrich
1Medical Clinic I, Hanau City Hospital, Germany.
Pacing and Clinical Electrophysiology : PACE
|September 1, 1992
Summary
A universal VS-1 adapter caused intermittent pacemaker failure due to unstable electric contact with side-lock connectors. Manufacturers need to disclose such hidden incompatibilities to prevent patient harm.
Area of Science:
- Biomedical Engineering
- Cardiovascular Device Technology
Background:
- Pacemakers are crucial for regulating heart rhythm in dependent patients.
- VS-1 adapters are intended to ensure reliable electrical connections for pacemaker systems.
Observation:
- A patient dependent on pacemaker function experienced intermittent loss of pacing and sensing.
- The issue arose after connecting a universal VS-1 adapter to a VS-1 receptacle.
Findings:
- The universal VS-1 adapter required pin deformation by a set screw for stable electrical contact.
- The patient's pulse generator used a screwless "side-lock" connector, resulting in a loose and unreliable connection.
- This incompatibility led to intermittent signal loss, compromising pacemaker function.
Implications:
- Manufacturers must clearly communicate compatibility requirements for medical device adapters.
- Unforeseen device incompatibilities pose significant risks to patient safety and treatment efficacy.
- Standardized testing and clear labeling are essential for universal medical device accessories.