MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LIFEBAND; CHEST COMPRESSION ASSEMBLY

Model Number 8700-0701

Device Problems Material Frayed (1262); Device Operates Differently Than Expected (2913)

Patient Problem Abrasion (1689)

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

The lifeband (s/n: (b)(4)) was returned to zoll for evaluation.The customer complaint of an edge of the lifeband was confirmed.Due to the discrepancies of the returned lifeband, the cause of the patient's abrasions could not be determined.Visual inspection was performed and found the belt guard (on the patient's right hand side) broken and the lifeband notch missing.The lifeband was used to perform testing on the returned autopulse platform and no issues were found.Death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr in cases of clinical death.Rosc was not achieved after both manual and mechanical cpr.The observed abrasion was unlikely to have caused or contributed to death.

Event Description

On (b)(6) 2016, it was reported that the responding clinicians noticed deep abrasions on the left side of the (b)(6) year old male patient's chest after the lifeband and autopulse platform were used.The hospital's clinician indicated the lifeband had an edge on it that was 'quite pronounced'.The patient had arrived earlier at the hospital's emergency department with asystole rhythm.Prior to arriving to the hospital, manual cpr was performed by an unknown person for an unspecified amount of time.The attending healthcare team deployed the autopulse platform.Despite attempts, the reporter indicated return of spontaneous circulation (rosc) was not achieved.Multiple attempts were made to contact the reporter to obtain additional information; however, was unsuccessful.There was no known consequence to the patient.

• Brand Name: AUTOPULSE® LIFEBAND
• Type of Device: CHEST COMPRESSION ASSEMBLY
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 6197344
• MDR Text Key: 63380630
• Report Number: 3010617000-2016-00946
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8700-0701
• Device Catalogue Number: 8700-0701-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR