MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-08-11 for HUDSON FOLDABLE MANUAL RESUS,DISP, ADULT W/FLO 5387 manufactured by Teleflex Medical.
[23384445]
(b)(4). It is unk if the device sample is available for eval.
Patient Sequence No: 1, Text Type: N, H10
[23384446]
A customer alleges that the medical staff wanted to use a resuscitation bag for a pt. When opening the code cart for the resuscitation bag and mask, it was discovered that the mask was totally deflated. The device was replaced. No pt injury or harm.
Patient Sequence No: 1, Text Type: D, B5
[25414490]
(b)(4). The sample was returned for evaluation. A visual exam was performed and it was observed that the hard shell of the returned mask was deformed and only a small amount of air was detected in the air cushion. The air cushion was filled with gas and then immersed into water and the air cushion was pressed hand. No bubbles or leakages were found. This product was manufactured in 2009 and it was out of the expiration date in 2012. It was determined that the air leaked naturally during the long time in storage.
Patient Sequence No: 1, Text Type: N, H10
[25414491]
The customer alleges that the medical staff wanted to use a resuscitation bag for a patient. When opening the code cart for the resuscitation bag and mask, it was discovered that the mask was totally deflated. The device was replaced. No patient injury or harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1044475-2015-00289 |
| MDR Report Key | 4999170 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-08-11 |
| Date of Report | 2015-07-21 |
| Date of Event | 2015-07-20 |
| Date Mfgr Received | 2015-09-01 |
| Date Added to Maude | 2015-08-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 2917 WECK DRIVE |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON FOLDABLE MANUAL RESUS,DISP, ADULT W/FLO |
| Generic Name | RESUSCITATION BAG |
| Product Code | NHK |
| Date Received | 2015-08-11 |
| Returned To Mfg | 2015-07-31 |
| Catalog Number | 5387 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-11 |