MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-12-23 for INTERTECH/INSPIRON 008001 N/I manufactured by Intertech Resources,inc..
[7931]
Patient being ventilated via resuscitation bag with peep valve attached to bag. The peep valve malfunctioned (1 way valve stuck in the closed position) and the patient was unable to passively exhale through the device. Subsequent stacking of breaths occurred and the patient experienced respiratory/cardiac arrest with bilateral pnaeumothorax. When the peep valve was examinaed by arespiratory therapist the valve wasa stuck in a closed position. Patient had cardio-respiratory arrest; resuscitationefforts were successful. The patient expired 12 days later. The cause of death is suspected hypoxic encephalopathy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 11704 |
| MDR Report Key | 11704 |
| Date Received | 1993-12-23 |
| Date of Report | 1993-11-29 |
| Date of Event | 1993-11-16 |
| Date Facility Aware | 1993-11-16 |
| Report Date | 1993-11-29 |
| Date Reported to FDA | 1993-12-09 |
| Date Reported to Mfgr | 1993-12-09 |
| Date Added to Maude | 1994-02-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERTECH/INSPIRON |
| Generic Name | POSISTIVE END EXPIRATORY PRESSURE VALVE |
| Product Code | CBP |
| Date Received | 1993-12-23 |
| Model Number | 008001 |
| Catalog Number | N/I |
| Lot Number | UNKNOWN |
| ID Number | PL-2956, PL-2958, D32030 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11704 |
| Manufacturer | INTERTECH RESOURCES,INC. |
| Manufacturer Address | FT. MYERS FL 33905 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1993-12-23 |