MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-11 for BREATH TECH 1/2 L HYPERINFLATION SYSTEM - MANOMETER + 40CM/H2O POP-OFF HS34051 manufactured by Sunmed Ap Ltd.
[136008453]
Infant in ldr 9 needed cpap assistance given via bag and mask. Pediatrician desired to give cpap with a peep of 5 (manometer would be at 5 when on patient), manometer did not move if it was off the patient or on the patient, it was stuck at 5. If bag/mask off patient, manometer should read 0. Manometer appears stuck. Bag/mask changed out (functioned properly). Faulty bag given to nicu manager.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083892 |
| MDR Report Key | 8331478 |
| Date Received | 2019-02-11 |
| Date of Report | 2019-02-08 |
| Date of Event | 2019-01-08 |
| Date Added to Maude | 2019-02-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BREATH TECH 1/2 L HYPERINFLATION SYSTEM - MANOMETER + 40CM/H2O POP-OFF |
| Generic Name | RESUSCITATOR TECH MANUAL NONSELF-INFLATING |
| Product Code | NHK |
| Date Received | 2019-02-11 |
| Catalog Number | HS34051 |
| Lot Number | 171200108 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SunMed AP LTD |
| Brand Name | BREATH TECH 1/2 L HYPERINFLATION SYSTEM - MANOMETER + 40CM/H2O POP-OFF |
| Generic Name | RESUSCITATOR TECH MANUAL NONSELF-INFLATING |
| Product Code | NHK |
| Date Received | 2019-02-11 |
| Catalog Number | HS34051 |
| Lot Number | 171200108 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-02-11 |